Gardnerella vaginalis (GV) is a gram-variable coccobacillus that has been discussed to be the sole causative agent of nonspecific vaginitis. Kretzschmar U, et al. “Purification and Characterization of Gardnerella vaginalis Hemolysin Curr. Microbiol. 23(1):7 13 (1991). Diagnosis and detection of this organism is often on the basis of the pathologic or clinical findings and may be confirmed by isolation and staining techniques. For example, in Kretzschmar et al., the basis for the detection and characterization of GV was the extracellular hemolysin produced by the organism. Gelber S., et al. “Functional and Phylogenetic Characterization of Vaginolysin, the Human Specific Cytolysin from Gardnerella vaginalis” J. Bacteriol. 190(11):3896 3903 (2008) identified another one of the extracellular hemolysins produced by GV as vaginolysin. Rottini, G., et al. “Identification and Partial Characterization of a Cytolytic Toxin Produced by Gardnerella vaginalis” Infect. and Immun. 58(11):3751 3758 (1990) identify the hemolysin produced by GV as cytolysin. The difficulties in isolating these toxins produced by GV are described in Cuaci S, et al. “Pore forming and haemolytic properties of the Gardnerella vaginalis cytolysin,” Mole. Microbio. 9(6):1143 1155 (1993)
Much has been written about the measurement and detection of the toxins produced by GV to detect GV. However, a method for detecting GV based upon the organism itself, as opposed to the toxins it produces, continues to be sought. Thus, there is a need for an assay that decreases the possibility of false negative results.
Citation or discussion of a reference herein shall not be construed as an admission that such is prior art to the present invention.